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Perioperative OutcomesNCT05457426

Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision

An observational study of Perioperative Outcomes and Oncological Outcomes, run by Third Military Medical University at 3 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Perioperative Outcomes, Oncological Outcomes
What is being tested?
robotic right hemicolectomy with CME
Type of treatment
Surgery or procedure
How many people
382 participants
Where
3 sitesChina
Study dates
1 Apr 2022to 22 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing; Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing; Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study

Who may be able to join

  • Adenocarcinoma was confirmed by preoperative colonoscopy and it was located in the right colon.
  • Preoperative enhanced abdominal CT examination showed no invasion of abdominal wall or adjacent organs.
  • The patient underwent robotic or laparoscopic right hemicolectomy with CME.

Who cannot join

  • Multiple primary colorectal tumors
  • Metastasis to abdominal
  • Pelvic or distant organs
  • Accompanied with bowel obstruction or perforation
  • Neuroendocrine tumors
  • Lymphomas
  • Other malignant tumors.

Trial locations and contacts

3 sites in 1 country.

China3 sites

  • No. 940 Hospital of Joint Logistics Support Foce of Chinese People's Liberation Army

    Lanzhou, Gansu, 730050

  • Chongqing University Three Gorges Hospital

    Wanzhou, Chongqing Municipality, 404031

  • Army Medical Center

    Yuzhong, Chongqing Municipality, 400042

Other trials in China

About this study

Official title: Robotic Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision: a Retrospective Multicenter Study With Propensity Score Matching

the investigators performed a retrospective multicenter propensity score matching study. From July 2016 to July 2021, 382 consecutive patients from different Chinese surgical departments were available for inclusion out of an initial cohort of 412, who underwent robotic or laparoscopic right hemicolectomy with CME.

Read the detailed description

All consecutive patients who underwent robotic or laparoscopic right hemicolectomy with CME from July 2016 to July 2021 at three Chinese surgical departments (Department of General Surgery, Army Medical Center, Chongqing;Department of Colorectum, Chongqing University Three Gorges Hospital, Chongqing;Department of Colorectum, the 940th Hospital of Joint Logistics Support Force of Chinese People's Liberation Army, Lanzhou) were included in the study. A retrospective review of multicenter institutional database was conducted. The Da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has been employed since 2016 in three centers. From July 2016 to July 2021, an initial cohort of 412 consecutive patients underwent robotic or laparoscopic right hemicolectomy with CME in three departments. With 30 cases meeting the exclusion criteria, 382 cases, including 204 males and 178 females, were available for inclusion. Of these, 149 cases by robotic right hemicolectomy with CME were classified as the robotic group, while the other 233 cases by laparoscopic right hemicolectomy with CME as the laparoscopic group.

Being tested
robotic right hemicolectomy with CME
Keywords
Robot, Right hemicolectomy, Complete mesocolic excision

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • robotic right hemicolectomy with CMEProcedure or surgery

    The distribution of trocars was placed according to the position of Intuitive Surgical Inc. for robotic colectomy. The robot was set to come and dock from theright shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R3), and Cadiere's fenestrated forceps in the right lower quadrant port (R2) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transversemesocolon with the grasp in R2, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R3.

Study groups in NCT05457426
Study groupRoleWhat they receive
robotic right hemicolectomy with CMEThe robot was set to come and dock from the right shoulder of the patient. Three robotic 8-mm trocars (R1, R2 and R3) and two 12-mm trocars (camera and assistant port) were used for the robotic procedure. One working arm carrying a monopolar cautery hook/scissors for dissection was located in the left upper quadrant port (R1). The other two working arms carried bipolar forceps in the suprapubic port (R2), and Cadiere's fenestrated forceps in the right lower quadrant port (R3) that was used to keep the superior mesenteric axis in traction. After gentle cephalad traction on the transverse mesocolon with the grasp in R3, the assistant grasped the ileocecal valve through the assistant port to put the ileocolic vascular pedicle on tension and the ileocolic vessels were identified and lifted up with R2. All procedures were performed keeping the principle of complete mesocolic excision.
Receives: Procedure: robotic right hemicolectomy with CME
laparoscopic right hemicolectomy with CMEIn the aparoscopic group, five trocars were used: a periumbilical incision and left upper quadrant for 12-mm trocars, both lower quadrants for 5-mm trocars, and the right quadrant for one more 5-mm trocar. A 30 degrees laparoscope was inserted through the periumbilical trocar site. After insertion of the trocars, the patient was placed in the Trendelenburg position with a 15 degrees rightward tilt. An ultrasonic device was used for dissection. All procedures were performed keeping the principle of complete mesocolic excision.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. diseasefree survival(months)

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

    Measured: until July 2021

  2. overall survival(months)

    Collect outcomes of follow-up and use Kaplan-Meier survival analysis to analyze it.

    Measured: until July 2021

Secondary outcomes (10)

  1. conversion rates

    the incidence of a conversion to open surgery

    Measured: during the surgery

  2. operative time

    the miniutes of surgery from skin to skin

    Measured: during the surgery

  3. estimated blood loss

    the mililiter of the blood loss during surgery

    Measured: during the surgery

  4. oral retake

    the patients begin to recover intake

    Measured: up to 30 days after surgery

  5. time to return to bowel function

    the patients begin to recover bowel function

    Measured: up to 30 days after surgery

  6. length of stay

    the days of hospital stay

    Measured: up to 30 days after surgery

  7. total hospitalization cost

    the total cost of this treatment by RMB

    Measured: up to 30 days after surgery

  8. complications

    Postoperative complications, such as ileus, anastomotic leak, small intestinal obstruction, bleeding and so on. Number of Participants with complications will be recorded.

    Measured: up to 30 days after surgery

  9. harvest lymph nodes

    the number of harvest lymph nodes in postoperative pathological report

    Measured: up to 7 days after surgery

  10. lymph node metastasis

    the number of patients with lymph node metastasis

    Measured: up to 7 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Jun 2022
  4. Study completion22 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
382 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05457426
Sponsor's protocol ID
20220623
Status last verified
Jul 2022
First submitted
23 Jun 2022
Last updated
21 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Yozgatli TK, Aytac E, Ozben V, Bayram O, Gurbuz B, Baca B, Balik E, Hamzaoglu I, Karahasanoglu T, Bugra D. Robotic Complete Mesocolic Excision Versus Conventional Laparoscopic Hemicolectomy for Right-Sided Colon Cancer. J Laparoendosc Adv Surg Tech A. 2019 May;29(5):671-676. doi: 10.1089/lap.2018.0348. Epub 2019 Feb 26.

    PubMed 30807257

  • Ferri V, Quijano Y, Nunez J, Caruso R, Duran H, Diaz E, Fabra I, Malave L, Isernia R, d'Ovidio A, Agresott R, Gomez P, Isojo R, Vicente E. Robotic-assisted right colectomy versus laparoscopic approach: case-matched study and cost-effectiveness analysis. J Robot Surg. 2021 Feb;15(1):115-123. doi: 10.1007/s11701-020-01084-5. Epub 2020 May 4.

    PubMed 32367439

  • Spinoglio G, Bianchi PP, Marano A, Priora F, Lenti LM, Ravazzoni F, Petz W, Borin S, Ribero D, Formisano G, Bertani E. Robotic Versus Laparoscopic Right Colectomy with Complete Mesocolic Excision for the Treatment of Colon Cancer: Perioperative Outcomes and 5-Year Survival in a Consecutive Series of 202 Patients. Ann Surg Oncol. 2018 Nov;25(12):3580-3586. doi: 10.1245/s10434-018-6752-7. Epub 2018 Sep 14.

    PubMed 30218248

Questions about this trial

What is this clinical trial studying?

An observational study of Perioperative Outcomes and Oncological Outcomes, run by Third Military Medical University at 3 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

diseasefree survival(months) (time frame: until July 2021). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05457426, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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